BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2760862 · Received September 26, 2012

    Report

    Report Number
    1416980-2012-00759
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 7, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED FOR EVALUATION, THE REPORTED CONDITION WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). THE SAMPLE WAS DISCARDED DUE TO CHEMOTHERAPY CONTAMINATION. SINCE THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THE CONDITION CANNOT BE CONFIRMED NOR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE CAN NOT BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER CANADIAN TECHNICAL SERVICES TO REPORT A CLEARLINK SYSTEM SECONDARY MEDICATION SET THAT'S USE RESULTED IN A CHEMO SPILL. THE CUSTOMER HAS INFORMED THAT THIS HAS HAPPENED TWICE BEFORE. THE TUBING COMES APART WHERE IT "CONNECTS TO THE LUER LOCK END. ONE OF THE CUSTOMER'S STAFF MEMBERS ADVISED THAT THEY HAVE NOTED THAT THE TUBING ON SOME OF THESE MEDICATION SETS DOES NOT APPEAR TO BE PUSHED COMPLETELY INTO THE LUER LOCK PIECE, THEY HAVE NOTICED VISUALLY THAT IT MAY ONLY BE ONLY PART WAY IN." THIS PROCESS STEP HAS BEEN IDENTIFIED TO BE DURING INFUSION. THERE WAS A PATIENT INVOLVED BUT THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE SR12D13027

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN CHEMOTHERAPY DRUG